A Review of the Talc Industry's Influence on Federal Regulation and Scientific Standards for Asbestos in Talc

Our plain-English summary of A Review of the Talc Industry's Influence on Federal Regulation and Scientific Standards for Asbestos in Talc, by T. Bird, J.E. Steffen, T.H. Tran, et al (New Solutions, 2021).

The study

• Authors: T. Bird, J.E. Steffen, T.H. Tran, D.S. Egilman
• Journal: New Solutions
• Published: 2021;31(2):152-169
• Type of article: Review
• Cited by: 10 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

The talc industry and Food and Drug Administration (FDA) have asserted that talc has been asbestos-free since 1976 when the industry created a voluntary specification for the asbestos content of cosmetic talc. However, recent evidence reveals that cosmetic talc is not and never was asbestos-free. This narrative review examines the talc industry's role in delaying and ultimately blocking federal regulation of cosmetic talc from the 1970s to today. We review primary source material, including corporate documents released in recent litigation and FDA documents released in response to Freedom of Information Act requests. Our results indicate that the talc industry exerted considerable influence over three key areas: regulatory proceedings at the FDA; testing methods and the manipulation of test results (including undisclosed results); and press coverage and the medical literature. The talc companies' actions and FDA indifference have had a lasting effect on consumer health, including the regulation of talc by other government agencies.

In plain English

This was a narrative review of documents. The authors examined corporate records released in talc litigation, FDA records obtained under the Freedom of Information Act, laboratory records and depositions. They traced how the talc industry, particularly Johnson & Johnson (J&J), dealt with federal regulators over asbestos in cosmetic talc from the 1970s on. They reported that a chemist hired by the FDA in 1972 found tremolite and/or chrysotile asbestos in 43 of 102 commercial talc product samples. On retesting he found 2-5 percent chrysotile in J&J Baby Powder and Shower to Shower, but a later version of the results reclassified these J&J results as "none detected". Companies did not give the FDA their own tests that found tremolite and chrysotile. The voluntary 1976 industry method, J4-1, did not test for chrysotile and detected amphiboles only above 0.5 percent. The FDA never issued a final regulation. The authors concluded that the claim that cosmetic talc has been asbestos-free since 1976 rests on that method, not on test results. They noted that their review was not exhaustive and was limited to the documents available to them.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Narrative review of primary source documents (historical case study), organized chronologically
• Who was studied: Documents rather than people: corporate documents from talc mining and manufacturing companies produced in litigation (a searchable database from Ingham v. Johnson & Johnson, St. Louis), FDA documents released under Freedom of Information Act requests, talc-related laboratory records, depositions, and published literature, covering the 1970s to the present
• Exposure: Asbestos (tremolite, chrysotile and other forms) and fibrous talc in cosmetic talcum powders, including J&J Baby Powder, Shower to Shower and Medicated Powder
• Main results:
  • In 1972 Dr. Seymour Lewin, hired by the FDA, reported tremolite and/or chrysotile asbestos in 43 of 102 commercial talc product samples, and 5% chrysotile in J&J Shower to Shower
  • Lewin's repeat tests on J&J products found 2-5 percent chrysotile in Baby Powder and Shower to Shower, and 4 percent tremolite in Medicated Powder
  • A second version of Lewin's results, dated 7 December 1972 and based on an acid-treatment analysis that can dissolve chrysotile, reclassified J&J products that had tested positive for chrysotile as none detected
  • The FDA's July 1973 report stated that of 195 samples tested, 17 were positive for chrysotile and 36 for tremolite asbestos; Lewin's tremolite findings in J&J products were left out
  • The companies did not give the FDA their own test results finding tremolite and chrysotile in products including baby powder, Shower to Shower, talc ore and ovarian tissue
  • In December 1974 J&J urged the CTFA to recommend methods to the FDA before more sensitive detection techniques developed
  • The 1976 CTFA J4-1 method was an unenforced specification that was never formally codified
  • The FDA never issued a final regulation for asbestos in talc and has not initiated any regulatory process for talc
  • In 2019 the FDA detected chrysotile in a J&J baby powder lot that had passed both the CTFA J4-1 method and J&J's transmission electron microscopy method TM7024
• The authors' conclusion: The authors concluded that the FDA and industry assertion that cosmetic talc has been asbestos-free since 1976 relies on publication of the 1976 J4-1 method, not on actual test results. They stated that the method permitted chrysotile and fibrous talc and detected amphiboles only at levels over 0.5 percent.
• Limitations the authors state:
  • The review is not exhaustive and much detail is omitted
  • The review was limited to the documents made available to the authors and those in the public domain

Topics

The National Library of Medicine indexes this study under subjects our site covers: Talc and vermiculite.

Medical terms in this study, explained in our Lexicon: Talc, Cosmetic Talc.

Related studies

• Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance — T.H. Tran, J.E. Steffen, et al. (2019)
• Serous Ovarian Cancer Caused by Exposure to Asbestos and Fibrous Talc in Cosmetic Talc Powders-A Case Series — J.E. Steffen, T. Tran, et al. (2020)
• Perineal talc use and ovarian cancer risk: a case study of scientific standards in environmental epidemiology — M. Huncharek, J. Muscat (2011)
• Cosmetic talc and ovarian cancer — D.L. Longo, R.C. Young (1979)
• Mesothelioma Associated With the Use of Cosmetic Talc — J. Moline, K. Bevilacqua, et al. (2020)
• Cosmetic talc as a risk factor for pleural mesothelioma: a weight of evidence evaluation of the epidemiology — B.L. Finley, S.M. Benson, et al. (2017)

Browse more research in New Solutions, or return to medical research.